SPECTRAFORCE · 12 hours ago
Clinical Development Scientist
United States
Contract
Remote
Mid, Senior Level
$100/hr - $135/hr
5+ years expSPECTRAFORCE is seeking a Clinical Development Scientist to participate in the development of clinical strategies for assigned modalities. The role involves designing, implementing, monitoring, and analyzing clinical studies, while collaborating with various stakeholders to ensure successful execution of clinical trials.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Lakshay Kumar
Responsibilities
Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs
Provides expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making
Serves on the clinical sub-team with GML, Operations Lead, and Medical Monitor/Study Physician and supports preparation of clinical development plans, site identification and management, and DESC meetings
Under the guidance of study physician/med lead, perform medical monitoring activities (Review, analyze and triage patient data, generating reports
Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan
Partners with GML in preparing for Health Authority (HA) Meetings and assists in addressing HA inquiries
Together with the GML and Product Responsible Person may prepare analysis for DMC/DSMB/DEC forums or regulatory submissions
Provides training at investigator meetings and site initiation visits with clinical trial staff, and partners with Clinical Operations and Medical Affairs in enabling appropriate enrollment into the clinical studies or registries. Collaborates cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums
Supports engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings)
Early and/or late phase studies
Exhibits expertise related to Study Data Review and Analysis:
Provides clinical input into statistical planning, data analysis and interpretation
Provides clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications
Works closely with operations group for site and vendor feasibility, trial set up and monitoring
May lead the execution of contracts, particularly for investigator meetings and advisories
Supports efforts to develop strategic partnerships with Key External Experts (KEEs)
Serve as key partner for Development Division in assessment of candidates within discovery, identifying opportunities and potential risks with future development strategies based on modality, indication, unmet need, competitive landscape and clinical characteristics
May represent development and assist with clinical assessment for due diligence(s) of new assets for potential in-licensing and acquisition
Supports strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested
Performs other duties as assigned or special projects as needed
Qualification
Required
Advanced degree in a relevant scientific discipline; health science or clinical discipline with typically 5-7 years clinical, scientific/research, pathology or industry related experience or combination of academia and industry
Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies
Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations)
Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Teams and MS Project) and in the use of industry-standard software (e.g. electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.)
Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including, Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance (PV)
Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities
Knowledge of global pharmacovigilance standards and guidance documents
Comfortable working in a flexible, dynamically changing and (at times) challenging environment
Excellent strategic planning, organizational and verbal and written communication skills
Ability to exercise sound judgment, tact, diplomacy and professionalism in all interactions
Aware of cultural diversity and how to influence and manage in a multi-cultural organization
Highest level of scientific integrity and impeccable work ethics
Preferred
Ph.D. or PharmD degree, or other relevant Master's degree
Knowledge and proficiency related to Medical Affairs activities including registries
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase